A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.

Status unconfirmed · Phase 2

Conditions studied: Hepatitis B

In brief

The purpose of the study is to evaluate the safety and effectiveness of 12 weeks of treatment with clevudine, at one of three doses, in patients chronically infected with hepatitis B virus.

Key facts

Study ID

NCT00044135

Run by

Triangle Pharmaceuticals

People needed

30

Starts

2002-08-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HBV DNA positive with DNA levels at screening greater than or equal to 3,000,000 copies/mL.
• Documented to be HBsAg positive for > 6 months OR HBsAg positive and IgM anti-HBc negative and anti-HBs negative. Patients may be HBeAg positive, and anti-HBe negative OR HBeAg negative (pre-core mutant) and anti-HBe positive.
• HBeAg positive and anti-HBe negative OR HBeAg negative (pre-core mutant) and anti-HBe positive with positive HBsAg for the previous 6 months
• AST and ALT levels which are less than or equal to 10 times the upper limit of normal.
• Bilirubin levels less than or equal to 1.5 x ULN or bilirubin levels > 1.5 x ULN with diagnosis of Gilbert's disease and conjugated bilirubin within normal limits.

You may not qualify if…

• Currently receiving antiviral, immunomodulatory or corticosteroid therapy
• Previous treatment with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection
• Previous treatment with interferon must have ended at least 6 months prior to screening visit
• History of ascites, variceal hemorrhage or hepatic encephalopathy
• Co-infection with HCV or HIV
• Evidence of cirrhosis or hepatocellular carcinoma (alpha fetoprotein)

Where it is running

• University of Illinois at Chicago — Chicago, Illinois, United States
• Thomas Jefferson University Hospital, Jefferson Medical College — Philadelphia, Pennsylvania, United States
• Viridae — Vancouver, Canada
• University of British Columbia, Downtown Infectious Disease Clinic — Vancouver, Canada
• Prince of Wales Hospital, Department of Medicine and Therapeutics — Hong Kong, China
• The University of Hong Kong, Clinical Trials Centre, Faculty of Medicine, Queen Mary Hospital — Hong Kong, China
• Hospital Beaujon, Service Hepatologie Centre Pierre Abrami — Clichy, France
• Hospital Dieu, Service Hepatogastroenterologie-endoscopie — Lyon, France
• Hospital St Louis, Service de Medecine Interne — Paris, France
• Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie — Vandœuvre-lès-Nancy, France
• National University Hospital, Division of Gastroenterology, Department of Medicine — Singapore, Singapore

Full record on ClinicalTrials.gov

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